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Parexel International
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D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS is an FDA 510(k)-cleared medical device (K112525) manufactured by Parexel International. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2011. Regulation: 8.